Kornimate/medical-research-clean huggingface dataset:
study of the safety and immunogenicity of long-term gnr-069 therapy in itp patients

Conditions: Idiopathic Thrombocytopenic Purpura

Summary: it is a phase iii extension study to assess safety and immunogenicity of long-term therapy with gnr-069 in patients with idiopathic thrombocytopenic purpura

it is an extension study in patients with itp who completed participation in rmp-itp-iii clinical trial. the study will be conducted in three stages: * transition visit - 1 day (transition of clinical trial participants from the rmp-itp-iii study to the rmp-itp-iii-x study); * treatment period - minimum 26 weeks; * follow-up period - 1 week. patients will then be provided with the study therapy till the product market access with only safety data collection.

Eligibility criteria:
inclusion criteria: * completion of participation in the study rmp-itp-iii while maintaining the clinical effectiveness of romiplostim therapy exclusion criteria: * hypersensitivity to the components of the study drug or e. coli proteins; * pregnancy or breastfeeding; * any diseases and conditions that, in the opinion of the investigator, may hinder the patient's participation in the study

Keywords: idiopathic thrombocytopenic purpura itp thrombocytopenia thrombocytopoiesis bleeding hemorrhagic syndrome petechial rash ecchymosis fc-peptide recombinant dna technology thrombopoietin receptors platelet formation fc fragment of human immunoglobulin igg 1 low platelet count itp treatment platelets haemorrhage platelet destruction impaired thrombopoiesis megakaryocytes autoantibodies splenectomy cytotoxic t cells thrombopoietin receptor agonists thrombopoietin receptor mimetic tpo-ras romiplostim nplate
efficacy and safety study for subjects with mild-to-moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a efficacy and safety study evaluating new treatment for subjects with mild to moderate alzheimer's disease.

this is a phase 2 study designed to evaluate the efficacy and safety of abt-126 in approximately 260 adults with mild-to-moderate alzheimer's disease (ad). subjects will be randomized to one of the four treatment groups (abt-126, donepezil, or placebo) for a 12-week treatment period. acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined: * mmse - mini mental status exam * qol-ad - quality of life - alzheimer's disease * cibic-plus - clinician interview-based impression of change * npi - neuropsychiatric inventory * csdd - the cornell scale for depression in dementia * adcs-adl - alzheimer's disease cooperative study - activities of daily living

Eligibility criteria:
inclusion criteria: * the subject is a male or female between the ages of 55 and 90 years, inclusive, at screening visit 1. * the subject meets the nincds/adrda criteria for probable ad. * the subject has a mini-mental status examination (mmse) total score of 10 to 24, inclusive, at screening visit 1. * the subject has a modified hachinski ischemic scale (mhis) score of less than or equal to 4 at screening visit 1. * if female, subject must be postmenopausal for at least two years or surgically sterile * the subject has an identified, reliable, caregiver. exclusion criteria: * the subject is currently taking or has taken a medication for the treatment of alzheimer's disease or dementia within 60 days prior to screening visit 1 * the subject has a history of any significant neurologic disease other than ad. * in the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness. * the subject has reported history of discontinuation of donepezil due to lack of efficacy. * the subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. * the subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or abt-126 formulations. * patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. * subjects with ast and alt values at screening visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (uln).
investigational study into transplantation of the uterus

Conditions: Mayer-Rokitansky-Kuster Syndrome; Asherson's Syndrome; Postpartum Hemorrhage; Cervical Cancer

Summary: observational study on cohort of 10 women undergoing uterine transplantation using deceased donors


Eligibility criteria:
inclusion criteria: 1. female 2. age - 24-38 (or 40 if eggs frozen \<38) 3. aufi 1. normal length vagina 2. no renal pathology 4. bmi \<30kg/m2 5. asa grade i 6. meet psychological criteria 7. meet hfea criteria for ivf 8. eligible for nhs treatment 9. speak fluent english exclusion criteria: 1. unsuccessful oocyte retrieval (\<10 good quality embryos) 2. previous multiple/significant surgeries 3. severe endometriosis 4. cancer patients \<5 years in remission 5. previous living childbirth, adopted child or child born through surrogacy 6. hiv or hepatitis b / c positive 7. skin or intestinal neovagina

Keywords: gynaecology immunosuppression in-vitro fertilisation infertility mrkh pregnancy transplantation uterus
defining exercise hemodynamics and function after transcatheter aortic valve replacement (define-tavr) study.

Conditions: Aortic Valve Stenosis

Summary: the purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise.

the objective of this single-center registry is to evaluate prosthetic valve hemodynamics and function over time in patients undergoing clinically indicated transcatheter aortic valve replacement (tavr) for symptomatic severe aortic stenosis. specific goals include: * describe valve hemodynamics at rest (baseline, post-procedure, 30 days, 1 year) and with exercise (at 30 days and 1 year) after tavr implantation to define valve function and hemodynamics over time. * compare valve hemodynamics and function at rest and exercise between self-expanding and balloon expandable valves.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female ≥18 years of age * clinically indicated for tavr * aortic annular size measures 21-25 mm diameter based on pre-procedure computed tomography angiography (cta) * able to exercise and, in the judgment of the investigator, is likely to be physically able to comply with the protocol requirements regarding exercise echocardiography * willing to comply with protocol-specified follow-up evaluations * the participant or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate institutional review board (irb) or ethics committee (ec) exclusion criteria: * previously implanted prosthetic aortic valve (i.e., planned valve-in-valve tavr) * known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year * left ventricular ejection fraction (lvef) \<35% * presenting with cardiogenic shock at the time of the index procedure * planned to undergo any cardiac surgical procedure in the following 12 months * the index procedure results in an unsuccessful tavr, defined as procedural major adverse events (death, disabling stroke, or life-threatening or disabling bleeding), need for a second prosthesis implant, or conversion to emergent surgery
lab school day study for concerta of older children with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this trial is to determine if the study medication, concerta (methylphenidate hcl), is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (adhd), when compared to placebo.

the hypothesis is that concerta (methylphenidate hcl) is safe and effective in improving academic performance and behavior in children with adhd, when compared to placebo as demonstrated using specified study measures. this is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral, and cognitive effects of concerta (methylphenidate hcl) on older children with adhd. this means that all eligible children will receive treatment with methylphenidate hcl throughout the study (the titration and assessment periods) and inactive pill (placebo) on one of the two laboratory classroom days. on the other laboratory classroom day they will receive their regular dose of methylphenidate hcl. the primary efficacy variable in this study is the permanent product math test (permp) attempted score. secondary measures include: skamp (swanson, kotkin, agler, m-flynn, and pelham), tests of inattention, reading fluency and comprehension, and memory. assessments will be completed during each of the laboratory assessment days (12.5 hours). participants will be assessed for adverse events throughout the study. patients will initiate treatment with oral concerta (methylphenidate hcl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. eligible patients will remain in the study for a maximum of 8 weeks.

Eligibility criteria:
inclusion criteria: * adhd diagnosis of all subtypes (except not otherwise specified) * patients with total or subscale attention deficit hyperactivity disorder rating scale (adhd rs-iv) scores \> =90th percentile relative to the general population of children by age and gender * patients currently receiving adhd medication must be inadequately managed on their current stimulant dose and meet this criteria at the screening visit * ability to read and understand english * ability to attend school regularly. exclusion criteria: * estimated full scale iq score of 80 or below * severe learning disability * history of, or current, primary diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, pervasive developmental disorder, eating disorder, obsessive-compulsive disorder, sleep disorder, major depressive disorder, bipolar disorder, substance use disorder, chronic tic disorder, personal or family history of tourette's syndrome * weight \< 3rd percentile for age * history of hospitalization for treatment of a mood, anxiety, or psychotic disorder * history of failed response to methylphenidate.

Keywords: adhd attention deficit hyperactivity disorder
validation of a correction factor for measurement of an accurate ankle-brachial index in the seated position

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to test a correction factor which would allow ankle brachial indexes taken in the seated position to accurately predict an ankle brachial index taken in the supine position.

peripheral arterial disease (pad) is a highly prevalent medical condition. patients with pad are usually diagnosed on the basis of a simple diagnostic procedure know as the ankle-brachial index (abi). the abi is the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms and legs using a hand-held doppler device. in order for the abi measurement to be accurate, the test is conducted with the patient in the supine position. this eliminates the influence of hydrostatic pressure on the ankle and toes which can lead to a falsely elevated reading. unfortunately, many patients are unable to lie supine for abi measurement, including: the wheel-chair bound, patients with degenerative disease of the spine or arthritis with chronic back pain, and patients with advanced cardiopulmonary disease and orthopnea. given the importance of detecting pad across a broad spectrum of patients, there is a need to identify a mechanism for reliable measurement of the abi for patients who cannot lie supine. the purpose of this study is to test a correction factor for the effects of hydrostatic pressure on the lower extremities to allow for accurate abi calculation in the seated position. 100 subjects with suspected arterial disease in the vascular lab will be enrolled. arm, ankle, and toe pressure measurements will be made in the supine and seated positions. the seated ankle pressures will be corrected for hydrostatic pressure using a mechanical formula. the abi and toe brachial index (tbi) will be calculated.

Eligibility criteria:
inclusion criteria: * patient at least 60 years of age * ambulatory outpatient * referred to non-invasive vascular laboratory for evaluation of suspected arterial disease. exclusion criteria: * unable to give informed consent * unable to lie supine for at least 15 minutes

Keywords: peripheral arterial disease pad ankle brachial index abi
improving supportive care for patients with thoracic malignancies

Conditions: Lung Cancer; Quality of Life; Supportive Care

Summary: the purpose of this study is to use a proactive approach to improve symptom management of patients with thoracic malignancies and ensure receipt of evidence-based cancer care delivery. in this pilot study, the investigators propose to evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies and ensuring evidence-based care receipt and measure the efficacy of this approach on patient satisfaction with their care, patient activation, quality of life and use of healthcare resources.

the investigators have previously shown in previous work that patients and caregivers who experience thoracic malignancies express poor symptom management that result in utilization of healthcare resources after-hours for symptoms that could have been prevented if assessed more proactively and prospectively. currently, there are limited proactive approaches to prospectively identify and intervene on patient-reported symptoms. the purpose of this study is to enhance symptom assessment strategies by using a proactive assessment approach to improve symptom relief for patients with thoracic malignancies. the investigators will test whether a proactive telephone symptom assessment and management strategy is feasible and can facilitate early patient report of their symptoms and intervention. the knowledge gained from this approach will be used to identify solutions that can be scaled nationally to improve patient-reported symptom management and patient satisfaction with their clinical care.

Eligibility criteria:
inclusion criteria: * all patients with lung cancer treated at va palo alto. this includes all newly diagnosed patients and those under follow-up care. exclusion criteria: * patients who do not anticipate receiving oncology care at the va palo alto health care system. * patients who are unable to consent.

Keywords: supportive care quality of life
bioequivalence study of doxazosin 4 mg orally-disintegrating tablet with or without water to doxazosin 4 mg japanese marketed immediate release tablet under fasted condition

Conditions: Hypertension

Summary: to test bioequivalence of doxazosin 4 mg orally-disintegrating tablet with or without water to doxazosin 4 mg japanese marketed immediate release tablet under fasted condition


Eligibility criteria:
inclusion criteria: * japanese healthy male subjects exclusion criteria: * baseline orthostatic hypotension defined as a ≥20 mm hg reduction in sbp, a ≥10 mm hg reduction in dbp and/or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.

Keywords: bioequivalence orally-disintegrating tablet
diacutaneous fibrolysis on lateral epicondylitis

Conditions: Tennis Elbow

Summary: diacutaneous fibrolysis (df) is a manual method of treatment, usually adjuvant, addressed to the mechanical pain of the locomotor system. in our clinical practice a favorable effect is observed in patients with chronic lateral epicondylitis, but there are no published studies evaluating the results of this technique. the objective of this trial is to evaluate if df provides a further improvement in pain intensity, pain-pressure threshold, function and pain-free grip strength, in patients with chronic lateral epicondylitis being treated with physiotherapy. for this purpose, we conduct a randomized controlled trial, double-blind (patient and evaluator) in a public primary care center. sixty subjects will be randomized (computer application) into three groups: intervention group, placebo group and control group. all the three groups receive the same protocolized treatment of physiotherapy and additionally. additionally, the intervention group receives six sessions (two sessions in a week during three weeks) of real df and the placebo group receives six sessions (two sessions in a week during three weeks) of sham df. the control group receives the protocolized treatment of physiotherapy only. pain intensity (vas), pain-pressure threshold (pressure algometry), function (dash questionnaire) and pain-free grip strength (digital dynamometer) will be measured at baseline, after treatment period, and three months after discharge from treatment. after discharge for treatment the patient subjective opinion about their evolution will be collected through the global rating of change (groc) scale.


Eligibility criteria:
inclusion criteria: * 18 years old and over * diagnosis of chronic lateral epicondylalgia * sign the informed consent form exclusion criteria: * concomitant conditions affecting the same upper extremity * contraindications for diacutaneous fibrolysis * corticosteroid injections or similar agents in the three months prior to study inclusion * pending litigation or legal claim * poor language and communication skills making difficult to understand the informed consent

Keywords: physiotherapy lateral epicondylitis manual therapy
beat the blues in pregnancy study - transcranial magnetic stimulation

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine if repetitive transcranial magnetic stimulation (tms) will alleviate symptoms of major depressive disorder (mdd) in pregnant women. tms uses electromagnetic impulses to encourage neurons in the brain to communicate more effectively with one another. effective neuron communication is thought to lead to the lessening of depressive symptoms. in this study subjects require daily tms treatment for approximately four weeks.

we hypothesize that there will be a decline in the hamilton rating scale for depression (hdrs-17) scores from the beginning to end of treatment. we expect that this decrease will be significantly greater in subjects receiving active transcranial magnetic stimulation (tms) compared to those receiving placebo tms. treatment response will be defined as greater than 50% reduction in hdrs-17 score. we also hypothesize that levels of brain derived neurotrophic factor (bdnf), a protein thought to regulate mood and cognitive functioning, will increase in subjects who respond to tms treatment. we expect bdnf levels to increase by greater than or equal to 20% in those who respond to tms. as previously stated, tms response will be defined as a significant decrease (50% or greater) in the hdrs-17 from baseline to end of treatment.

Eligibility criteria:
inclusion criteria: * subjects are capable of giving written informed consent and complying with all study procedures; * female age 18-39 years old at date of enrollment; * pregnant, weeks 14-34; * current depressive symptoms; * no change in antidepressant medication at least two weeks prior to study entry if using an antidepressant. exclusion criteria: * any alcohol or drug abuse/dependence over the 6 months prior to study entry; * history of a seizure disorder in subject or first degree relative; * anti-psychotic, lithium, or anti-convulsant medications within 2 weeks of study enrollment; * history of known brain lesions, or severe head trauma; * subjects with any metallic object implanted in the skull; * subjects with significant cardiac disease; * neurological or psychiatric disorders; * serious medical illnesses that may compromise patient safety or study conduct; * currently taking a drug with known potential for fetal toxicity; * previous pregnancy with an adverse fetal outcome; * current obstetrical complications * actively suicidal; * history of depression unresponsive to treatment with electroconvulsive therapy (ect).

Keywords: major depressive disorder pregnancy brain derived neurotrophic factor transcranial magnetic stimulation
prospective electroencephalography evaluation of sedation in covid-19

Conditions: Conscious Sedation; Pathologic Processes; Electroencephalogram; Acute Respiratory Distress Syndrome; Corona Virus Infection

Summary: sedation of severe covid-19 disease are often complicated. we try to find a correlate for this observation by encephalographic studies.

sedation of critically ill ventilated coronavirus patients, continues to be a challenging issue. also, neurological symptoms of severe covid-19 disease have been described frequently. difficulties in sedation of these patients have been discussed repeatedly. the aim of this study is to investigate whether an encephalographic correlate can be found. appropriate processed encephalographic techniques have been used for anesthesia monitoring for many years. the aim of our study is to collect unrelated processed and raw eeg data of sedated covid-19 patients and to investigate the correlation to the necessary sedation.

Eligibility criteria:
inclusion criteria: intubated ventilated patients with sars-cov-2 associated acute respiratory distress syndrome and sedation difficulty. exclusion criteria: pre-existing severe cerebral brain damage and dysfunction. for example: previous medial infarction, cerebral hemorrhage, structural epilepsy.
diagnostic value of ultralow-dose computed tomography for the detection of pulmonary nodules and lung parenchym alterations compared to standard-dose ct

Conditions: Multiple Pulmonary Nodules; Pulmonary Emphysema

Summary: to investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-ct.


Eligibility criteria:
inclusion criteria: * planned normal dose-ct by clinical indication at our institution * obtained informed consent exclusion criteria: * planned lowdose-ct by clinical indication at institution * no informed consent obtained * age \< 18 years * pregnancy
mechanisms of orthopnea in stable obese patients

Conditions: Obesity

Summary: the purpose of this study is to study the role of closing volume as a determinant of orthopnea in stable obese subjects. the investigators hypothesized that: (1) increase in closing volume in supine position would be greater in orthopneic than in non-orthopneic subjects, and (2) the relationship of change in closing volume to change in dyspnea with position would be dependent on expiratory flow limitation in the sitting position. in stable obese subjects, in sitting and supine positions, the investigators measured borg dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen expiration test, from which the investigators determined closing volume and closing capacity, slope of phase iii, and opening capacity. orthopnea was defined as any increase in the borg score in the supine position from its value in the sitting position


Eligibility criteria:
inclusion criteria: * obese (bmi ≥ 30) * stable condition * 20 \< age \< 60 years exclusion criteria: * other respiratory disorder (copd) * left cardiac insufficiency

Keywords: closing volume expiratory flow limitation obesity orthopnea